by According to two new studies, many DIY health tests that are available in High Street are for purpose and require better regulation.
Self-tests for high cholesterol, vitamin deficiency, fertility and prostate problems are widespread in supermarkets and pharmacies, with the industry probably worth 655 million GBP by 2030.
However, researchers from the University of Birmingham have found that many tests could deliver false results to users and were not always appropriate or safe.
The scientists examined 30 DIY health tests that cost £ 1.89- £ 39.99 and covered 19 different health conditions. This included vitamin -D deficiency, blood sugar levels, thyroid function, prostate health, HIV, menopause and colon cancer.
The two studies published in the British Medical Journal (BMJ) rated 60% of the tests as a “high risk” of concerns with regard to the test devices, sample process or the instructions and the interpretation of the results. Only eight indicates who the tests were suitable for, while less than half provided information about the accuracy. And a large part of the evidence of supporting these claims was not publicly available or of low quality.
For many tests that recommend the user to pursue your family doctor or another health profession regardless of the result, this raises the question: “What does it bring to carry out the test in the first place?” Said Dr. Clare Davenport, Associate Clinical Professor at the University of Birmingham and Co-Lace Author of the Studies.
“The wide range of tests now available to the public is not approved by the NHS and there is no evidence of their benefits,” she added. “In contrast to well -established self -tests such as pregnancy tests, this is in contrast.
“We are concerned that consumers who are concerned about their health and are tempted by the convenience of buying a test via the counter if they use these tests incorrectly.”
The studies require better regulation of DIY health tests to protect patients and prevent abuse. Prof. Jon Deeks from the University of Birmingham and co-lead author of the studies said: “Self-tests have a clear potential to improve public health. However, so that they are advantageous and not harmful, they must be proven to be correct and supported by clear instructions. We hope that MHRA is MHRA. [Medicines and Healthcare products Regulatory Agency] Updates the regulatory process to ensure that self -tests are effective and safe for everyone. “
Joseph Burt, the head of the diagnostic and General Medical Devices at MHRA, said: “We take the security of self-tests very seriously. We will check the evidence presented by the researchers and take into account all accusations of device accidents.
“We have increased the surveillance powers according to the market for concerns. These require manufacturers to actively monitor their products and report significant incidents, including CE brand tests.
“We overtake the regulations for medical devices to further strengthen the standards for security, user-friendliness and clinical performance-and we are examining new transparency measures, such as: [Conformité Européene] Or Ukca [UK Conformity Assessed] Mark the instructions carefully and look for medical advice if you are not sure that you are about your result. “
Prof. Kamila Hawthorne, Chairman of the Royal College of GPS, said: “With the risk of false positive and negative negative and no offer for interpreting the results or aftercare, self-test kits can mean that patients have a significant amount of stress and fear, they ask to ask themselves from their GP to interpret all results.
“This not only has a negative effect on our patients, but can also intensify the enormous pressure that GPS and its teams are currently subject to. Commercial self-test kits should not be in the NHS all-community medicine as a provider for the next steps and follow-up, unless the test has been initiated in basic care or as part of a commissioned NHS service.”
